Senior TPM QA Engineer

Employer
Abbott Laboratories
Location
Saint Paul, MN
Closing date
Jan 24, 2022

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Sector
Science, Physical Sciences and Engineering, Pharmaceutical, Quality Assurance
Organization Type
Corporate
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Senior TPM QA Engineer - St. Paul, MN

ABOUT ABBOTT

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

We are recruiting for a Senior TPM QA Engineer to join our team in the St. Paul, MN location. In this role, you will provide support in the selection, approval, maintenance and day to day QA operations of SH's approved Third Party Manufacturing (TPM) by assisting, as an SME, in the performance of supplier / TPM quality system assessments, monitoring TPM performance, support at the TPM locations (either on site or remotely) to ensure that the TPMs consistently product high quality product, plant compliance and providing support for product quality, safety and regulatory issues. You will also be responsible for supplier corrective action and/or improvement activities and leading the development of and maintaining Supplier Controls (specifically TPM) quality system and providing quality system support for the site and/or division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).

Responsibilities:
  • Responsible for managing Third Part Manufacturers, which are suppliers that procure, assemble, test, accept and package products for distribution on SH's behalf
  • Development and implementation of a more robust TPM quality system suitability for new product development and commercialized product
  • Initiate and maintain and active line of communication with Manufacturing QA Leaders on critical quality issues that may result in potential business interruption
  • Provides support to TPMs during external regulatory body audits
  • Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate
  • Provides support to TPMs during external regulatory body audits
  • Trains Third Party Manufacturers on inspecting products on the behalf of ADC: Supplier Certified Inspector Program
  • Notifies TPMs of customer complaints related to failures resulting from supplied material and requires investigation and corrective action
  • Leads in the evaluation and approval of supplier requested changes or improvements
  • Interface directly with all levels of personnel within the TPMs, including Senior Management and influence QA Operations and overall compliance of the facilities to the highest regulatory standards
  • Evaluates Non-conformances and CAPAs for nonconforming supplied material and works with the TPM on the investigation and resolution of root cause issues

EDUCATION AND EXPERIENCE YOU'LL BRING

Required:
  • Bachelor's Degree in Engineering, Sciences, or related discipline
  • 4+ years of supplier quality engineer experience within a regulated industry (i.e. medical device, Pharmaceutical, Aerospace, etc)
  • Proficient with MS Office (Word, Excel, Outlook)
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Preferred:
  • Advanced degree in Engineering, Sciences, or related discipline
  • Medical device experience

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

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